By Stewart Eisenhart, Emergo Group
Mexican medical device regulator COFEPRIS plans to establish a new device category, Class 1A, for nearly 100 products currently exempt from registration requirements.
Items on the list include tongue depressors, nasal aspirators, umbilical tapes and clamps, gauze, compression bandage systems and bandages.
According to our sources in Mexico, implementation of the new requirement will happen sometime in the next three months, and COFEPRIS has yet to issue details of how affected manufacturers will have to register their devices in order to comply with Class 1A rules.
We will keep you informed as we learn more about this development.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.